A Non-Randomized, Open-Label, Single Center Phase 4 Study of the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (Laser, Anti-VEGF) With or Without Intravitreal Corticosteroid Therapy

• ClinicalTrials.gov Identifier: NCT02472366
• Recruitment Status: Completed
• First Posted: June 15, 2015
• Results First Posted: September 16, 2015
• Last Update Posted: September 16, 2015
• Sponsor: Alimera Sciences
• Information provided by (Responsible Party): Alimera Sciences

Study Description

Brief Summary:

A phase 4 trial evaluating the effect and safety of ILUVIEN in chronic DME patients insufficiently responsive to available therapies.

Condition or disease	Intervention/treatment	Phase
Chronic Diabetic Macular Edema	Drug: ILUVIEN	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: January 2014
• Actual Primary Completion Date: March 2015
• Actual Study Completion Date: May 2015

Arms and Interventions

Arm	Intervention/treatment
laser; laser with or without prior history of intraocular corticosteroid therapy	Drug: ILUVIEN
laser and anti-VEGF; laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy	Drug: ILUVIEN

Outcome Measures

Primary Outcome Measures :

1. Changes in Best Corrected Visual Acuity From Baseline [ Time Frame: Change from Baseline to 12 months post ILUVIEN administration ]
   Best Corrected Visual Acuity is measured using an ETDRS eye chart and is reported as the number of letters read correctly in the study and/or fellow eye.

Secondary Outcome Measures :

1. Changes in Intraocular Pressure (IOP) [ Time Frame: Change from Baseline to 12 months post ILUVIEN administration ]
2. Changes in Central Subfield Thickness [ Time Frame: Change from Baseline to 12 months post ILUVIEN administration ]
3. Changes in Macular Volume [ Time Frame: Change from Baseline to 12 months post ILUVIEN administration ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Patients ≥18 years of age, of either sex that have signed informed consent / been well informed by the treating physician.
2. DME based on investigator's clinical evaluation and demonstrated using fundoscopic photography and spectral domain OCT.
3. Mean central foveal thickness (central subfield thickness) ≥350 microns in the study eye as measured using spectral domain OCT.
4. Vision impairment (20/60 to 20/400 using Snellen visual acuity equivalent) related to DME.
5. Previous treatment in the study eye with laser photocoagulation for DME, including focal/grid and pan-retinal, at least 3 months prior to the screening visit and ≥3 monthly anti-VEGF treatments (group 1).
6. Previous treatment in the study eye with laser photocoagulation for DME at least 3 months prior to the screening visit (group 2) and treatment with an intraocular anti-VEGF therapy not possible.
7. Patients considered as insufficiently responsive to prior therapy for DME, as defined by the study physician.

Exclusion Criteria:

1. IOP >21 mmHg at screening in the study eye.
2. Historical rise in IOP >25 mmHg following treatment with an intravitreal corticosteroid in the study eye.
3. Use of ≥2 IOP-lowering medications to control IOP at screening in the study eye.
4. Patients that have vitreomacular traction in DME and opaque media in the study eye.
5. Patients with severe proliferative diabetic retinopathy requiring pan retinal photocoagulation in the study eye.
6. Pregnant or breastfeeding.
7. Patients diagnosed with active angiographic central vein ischaemia prior to screening in the study eye.
8. Patients that have received pan retinal photocoagulation or undergone cataract surgery in the 3 months prior to the study start date in the study eye.

9. Patients with contraindications according to the current SPC:

   1. The presence of pre-existing glaucoma.
   2. Active or suspected ocular or periocular infection.
   3. The patient is hypersensitive to the active agent or to one of the excipients.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Alimera Sciences
• ClinicalTrials.gov Identifier: NCT02472366
• Other Study ID Numbers: M-01-13-002
• First Posted: June 15, 2015
• Results First Posted: September 16, 2015
• Last Update Posted: September 16, 2015
• Last Verified: August 2015

Additional relevant MeSH terms:

Macular Edema; Edema; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Fluocinolone Acetonide; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs